Perform routine micro testing, e.g. bioburden, sterility test etc., and deliver report in time进行常规的微生物测试,例如:生物负载、无菌测试等,并及时出具报告Perform CA, PW and environmental monitoring and other process including culture/media preparation压缩空气、纯化水和环境监测以及菌种/培养基制备等其他日常工作Review data obtained for compliance to specifications and report abnormalities审核获得的数据是否符合质量标准以及报告的异常性Troubleshoot microbiological OOS occurrences and support change controls, CAPAs and investigations解决微生物OOS问题及协助变更控制,CAPAs和调查Plan, write, perform and follow method validation, equipment qualification, cleaning validation and sterilization validation protocols/reports计划、编写、执行和跟踪方法验证、设备确认、清洁验证和灭菌验证相关方案/报告Perform required calibration/maintenance on microbiological equipment对微生物设备执行所要求的校验/维护Ensure safe working in accordance with cGMP/HSE guideline at all time始终按照cGMP/HSE规范确保安全工作To review data and perform the data trend analysis, complete the related annual summary report审核数据,并完成数据趋势分析,完成相关项目的年度总结报告Other tasks assigned by the supervisor主管分配的其他工作